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A LIVE ROUNDTABLE WITH THE EXPERTS: The Importance of Maintaining Data Integrity in Digital Transformation Strategies

By Webmaster Lachman Nov 02, 2022 Uncategorized

Wednesday, November 16th, 10:00 AM ET Presented by Informa Pharma Intelligence and Lachman Consultants HOSTED BY Maire Gerrard Managing Editor, Custom Content, Pharma Intelligence The life sciences industry is currently experiencing a period of sweeping digital transformation, propelled by initiatives like Pharma 4.0™ and progress in embedding artificial intelligence (AI), machine learning (ML), and robotic […]

Nov

Bob Pollock Appointed to Dispensary of Hope National Advisory Council

By Webmaster Lachman Nov 02, 2022 Uncategorized

Dispensary of Hope, a Nashville-based organization with a national model of medication access for the most vulnerable, has appointed Robert “Bob” Pollock, M.S., Senior Advisor, Outside Director to the Board at Lachman Consultants, Inc. to its National Advisory Council. The organization’s many years of growth and commitment to serve are empowered by individual servants and […]

Nov

OTC Monograph User Fee (OMUFA) Draft Guidance Published Today

By Bob Pollock Nov 01, 2022 FDA OTC Regulatory Affairs User Fees

For those of you in the OTC monograph world (not OTC products that require an approved NDA or ANDA application for marketing), this draft guidance document, titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (here), will provide you with the how, what, and when information about facility fees for dosage-form manufacturers […]

Oct

Data Integrity Series: Episode 6

By Scott Deckebach Oct 26, 2022 Compliance Data Integrity Emerging trends Laboratories Manufacturing Medical Devices Pharma 4.0

Data integrity is not only fundamental to a company’s license to operate and to drive new stakeholder value. It’s simply smart business. Does your company have a sustainable, cost-effective global data governance program? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely […]

Oct

Marty Shimer to Speak at AAM’s GRx+Biosims Meeting

By Webmaster Lachman Oct 25, 2022 News

On Tuesday, November 8, 2022, as part of the GRx+Biosims conference being held by the Association for Accessible Medicines, Marty Shimer will be participating on a panel in the Science and Regulatory Learning Track on pH Adjusters and Q1/Q2 Assessments. This session will explore FDA’s plans for pH adjusters and Q1/Q2 assessments and provide industry […]

Oct

ARE YOU BEHIND?

By Webmaster Lachman Oct 25, 2022 Combination Products Compliance Device FDA Regulatory Affairs

The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices conference was held in Palm Springs, CA, October 18-19, 2022. In attendance were some of the world’s largest providers in this combination space which included innovators, pharmaceutical companies, suppliers of injectable devices and contracted service providers. The conference speakers presented on a variety of topics […]

Oct

In a Very Topical Manner, FDA Introduces Guidance Documents to Get Under Your Skin

By Bob Pollock Oct 24, 2022 Bioequivalence FDA Generics Regulatory Affairs Topical products

Last Friday, FDA issued four (4) guidance documents that establish the FDA’s current thinking on requirements for establishing sameness and bioequivalence of topical products. They cover in vitro permeation testing, in vitro release studies, Q3 characterization studies, and studies required for corticosteroids of medium and high potency. While there have been many documents and discussions […]

Oct

FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

Compounding 5% Rule Enforcement Date Extended

By Bob Pollock Oct 21, 2022 Compliance Compounding FDA Regulatory Affairs

For those facilities compounding drug products and distributing them out of state, the FDA has extended the statutory enforcement date. On the Federal Register prepublication page this morning, the Agency announced that it is “extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products […]

Oct

AD Coms 14-1 Vote to Remove Makena from the Market Could Up the Ante on Accelerated Approvals

By Bob Pollock Oct 20, 2022 Accelerated Approval FDA Regulatory Affairs

As the pace of accelerated approvals has increased over the past few years, and as the number of withdrawals of accelerated approvals for some indications and products has also increased, the latest FDA move to seek removal of Makena, the premature birth preventative, for lack of efficacy could spell trouble for firms that cannot demonstrate […]

Oct

Mid-Month Peak at OGD Approval Actions

By Bob Pollock Oct 19, 2022 ANDAs Approvals FDA Generics Regulatory Affairs

This is the first month of GDUFA III and thus the first month of FY 2023! For approval actions posting through October 19th which include approvals posting through October 17th (postings are usually one or two days behind the actions taken), OGD has issued 22 full approval actions and 6 tentative approval actions for a […]

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The Lachman Blog

A LIVE ROUNDTABLE WITH THE EXPERTS: The Importance of Maintaining Data Integrity in Digital Transformation Strategies

Bob Pollock Appointed to Dispensary of Hope National Advisory Council

OTC Monograph User Fee (OMUFA) Draft Guidance Published Today

Data Integrity Series: Episode 6

Marty Shimer to Speak at AAM’s GRx+Biosims Meeting

ARE YOU BEHIND?

In a Very Topical Manner, FDA Introduces Guidance Documents to Get Under Your Skin

Compounding 5% Rule Enforcement Date Extended

AD Coms 14-1 Vote to Remove Makena from the Market Could Up the Ante on Accelerated Approvals

Mid-Month Peak at OGD Approval Actions

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